Bio Compression Systems Custom 8 Chamber Leg Sleeve

GUDID 00812311020116

Bio Compression Systems, Inc

Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable
Primary Device ID00812311020116
NIH Device Record Key67d86a12-1c2a-4063-aae3-0a62c3fad9ff
Commercial Distribution StatusIn Commercial Distribution
Brand NameBio Compression Systems Custom 8 Chamber Leg Sleeve
Version Model NumberC8-3045-C
Company DUNS101393924
Company NameBio Compression Systems, Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(201)340-6422
Emailbarbaraw@biocompression.com
Phone+1(201)340-6422
Emailbarbaraw@biocompression.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100812311020116 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JOWSLEEVE, LIMB, COMPRESSIBLE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-01-29
Device Publish Date2017-11-21

Devices Manufactured by Bio Compression Systems, Inc

00812311026255 - BioCryo Sequential Circulator2022-04-21
00812311020062 - 8-Chamber Arm & Shoulder Sleeve - Medium, Left2021-09-09 https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
00812311020208 - 8-Chamber Arm & Shoulder Sleeve - Medium, Right2021-09-09
00812311021700 - Bio Compression Systems 8 Chamber Leg Sleeve - Large2021-09-09
00812311021717 - Bio Compression Systems 8 Chamber Leg Sleeve - Medium2021-09-09
00812311021724 - Bio Compression Systems 8 Chamber Leg Sleeve - Small2021-09-09
00812311021731 - Bio Compression Systems 4 Chamber Leg Sleeve Large Narrow2021-09-09
00812311021816 - Bio Compression Systems 4 Chamber Leg Sleeve Medium Narrow2021-09-09

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